FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1070907
·
Received July 3, 2008
Report
- Report Number
- 6000034-2008-00376
- Event Type
- Injury
- Date Received
- July 3, 2008
- Date of Event
- October 13, 2006
- Report Date
- June 12, 2008
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS A FINAL REPORT. THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.
Description of Event or Problem · 1
THE PT'S DEVICE WAS EXPLANTED IN 2006, DUE TO AN INFECTION. NO FURTHER INFO WAS PROVIDED ABOUT THE INCIDENT. THE PT WAS REIMPLANTED WITH A NEW DEVICE ON EVENT DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | COCHLEAR LTD. | CI24M | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Required Intervention |